Anti-insulin-like Growth Factor-1 Receptor (IGF-1R) Antibodies in Graves' Disease and Graves' Orbitopathy

Graves Disease Clinical Trial

— IGF1RAbsGO  

Official title:

Serum Antibodies Against the Insulin-like Growth Factor-1 Receptor (IGF-1R) in Graves' Disease and Graves' Orbitopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498417
• Other study ID #: IGF1-R-Abs
• Status: Completed
• Start date: June 20, 2018
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2018
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is aimed at assessing IGF-1R-Abs in patients with Graves' disease, with or without GO, compared with healthy subjects and patients with autoimmune thyroiditis in a cross-sectional investigation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. for Graves' disease: a history of hyperthyroidism, associated with previous or present detectable serum autoantibodies against the TSH-R;

2. for autoimmune thyroiditis: the presence of at least two of the following: a) primary hypothyroidism; b) detectable serum autoantibodies against thyroglobulin or thyroperoxidase ; c) a hypoechoic pattern of the thyroid by ultrasound examination.

3. for healthy subjects: absence of any clinical, biochemical or instrumental evidence of thyroid diseases.

For all subjects: Informed consent

Exclusion Criteria:

1) lack of informed consent

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Eye Diseases
• Graves Disease
• Graves Ophthalmopathy
• Hashimoto Disease
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Diagnostic Test:
• Serum antibodies against the IGF-1R
Measurement of antibodies against the IGF-1R in serum samples by ELISA

Locations

Country	Name	City	State
Italy	Endocrinology Unit I, University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serum IGF-1R-Abs above the upper normal levels	Percent prevalence of serum IGF-1R-Abs above the upper normal levels in patients with GO, compared with healthy subjects, patients with Graves' disease without a clinically relevant GO, and patients with autoimmune thyroiditis.	Baseline
Secondary	Serum concentrations of IGF-1R-Abs	Comparison of the serum concentrations of IGF-1R-Abs in patients with GO, compared with healthy subjects, patients with Graves' disease without GO, and patients with autoimmune thyroiditis;	Baseline
Secondary	Relationship between serum IGF-1R-Abs and the activity of GO	Relationship between serum IGF-1R-Abs (both levels and prevalence), with the the activity GO, namely the clinical activity score, including 7 items (spontaneous orbital pain, gaze provoked pain, palpebral redness, palpebral oedema, conjuctival redness, caruncle edema, chemosis) resulting in a score from 1 to 7	Baseline
Secondary	Relationship between serum IGF-1R-Abs and anti-TSH receptor autoantibodies	The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyrotropic hormone-receptor serum autoantibodies	Baseline
Secondary	Relationship between serum IGF-1R-Abs and anti-thyroperoxidase autoantibodies	The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroperoxidase serum autoantibodies	Baseline
Secondary	Relationship between serum IGF-1R-Abs and anti-thyroglobulin autoantibodies	The relationship between serum IGF-1R-Abs (both levels and prevalence) and anti-thyroglobulin serum autoantibodies	Baseline